SOCRA - Society of Clinical Research Associates ICH Good Clinical Practice Questions and Answers 1 — Questions and Answers
Question 1: According to ICH GCP E6(R2), which of the following is a primary responsibility of the clinical trial Sponsor?
- Obtaining informed consent from trial participants.
- Making medical decisions for subjects during the trial.
- Ensuring the accuracy of source data at the investigational site.
- Selecting qualified investigators and ensuring proper monitoring of the trial. (Correct answer)
Correct answer: Selecting qualified investigators and ensuring proper monitoring of the trial.
ICH GCP E6(R2) Section 5 clearly outlines the sponsor's responsibilities. Section 5.6 specifies that the sponsor is responsible for selecting qualified investigators and institutions. Furthermore, Section 5.18 details the sponsor's responsibility for ensuring adequate trial monitoring to verify the protection of human subjects and the quality of the data. While the investigator is responsible for obtaining consent and ensuring data accuracy at the site, the ultimate oversight and qualification assessment lies with the sponsor.
Question 2: An investigator at a clinical trial site realizes that a study participant was inadvertently enrolled despite not meeting a key inclusion criterion. According to ICH GCP principles, what is the MOST appropriate immediate action for the investigator to take?
- Continue the participant in the trial but exclude their data from the final analysis.
- Inform the participant that they are being withdrawn from the study and document the event.
- Take appropriate measures to protect the participant's safety and well-being, document the deviation, and report it to the sponsor and IRB/IEC as required. (Correct answer)
- Wait for the next monitoring visit to discuss the issue with the Clinical Research Associate (CRA).
Correct answer: Take appropriate measures to protect the participant's safety and well-being, document the deviation, and report it to the sponsor and IRB/IEC as required.
ICH GCP emphasizes the paramount importance of protecting the rights, safety, and well-being of trial subjects. When a protocol deviation like this occurs, the investigator's first priority is the subject's safety. The investigator must then document the deviation and report it to the sponsor and the IRB/IEC according to their respective policies and regulatory requirements to ensure transparency and proper oversight.
Question 3: Which of the following documents must be on file at the investigational site BEFORE the clinical phase of a trial begins?
- Final clinical study report.
- A signed and dated protocol, current Investigator's Brochure, and IRB/IEC approval. (Correct answer)
- Completed Case Report Forms for all enrolled subjects.
- Monitoring visit reports and follow-up letters.
Correct answer: A signed and dated protocol, current Investigator's Brochure, and IRB/IEC approval.
ICH GCP E6(R2) Section 8.2 outlines the essential documents required before the clinical phase of a trial commences. These include a signed protocol agreed upon by the investigator and sponsor, the current Investigator's Brochure containing all relevant information about the investigational product, and documented approval from the Institutional Review Board/Independent Ethics Committee (IRB/IEC) for the protocol and informed consent form.
Question 4: During the informed consent process, the investigator must ensure that the potential participant understands all of the following EXCEPT:
- The complete formulation and manufacturing process of the investigational product. (Correct answer)
- That the trial involves research and the purpose of the trial.
- The trial procedures, foreseeable risks, and potential benefits.
- That their participation is voluntary and they may withdraw at any time.
Correct answer: The complete formulation and manufacturing process of the investigational product.
ICH GCP E6(R2) Section 4.8.10 details the elements that must be included in the informed consent discussion and form. These elements focus on ensuring the participant can make a voluntary and informed decision. They include the study's purpose, procedures, risks, benefits, and the voluntary nature of participation. While the Investigator's Brochure provides detailed product information to the investigator, the complete proprietary manufacturing process is not a required element for the participant's informed consent.
Question 5: Source data in a clinical trial, as defined by ICH GCP, must be ALCOA-C. What does the 'C' in this acronym stand for?
- Certified
- Contemporaneous
- Complete (Correct answer)
- Confidential
Correct answer: Complete
The acronym ALCOA-C (or ALCOA+) refers to the standards for high-quality data. It stands for Attributable, Legible, Contemporaneous, Original, Accurate, and Complete. 'Complete' means that the data includes all pertinent observations for that subject, without missing information.
Question 6: Which entity is responsible for safeguarding the rights, safety, and well-being of all trial subjects and must review and approve the clinical trial protocol and informed consent form before the study begins?
- The Sponsor
- The lead Clinical Research Associate (CRA)
- The Institutional Review Board / Independent Ethics Committee (IRB/IEC) (Correct answer)
- The regulatory authority (e.g., FDA)
Correct answer: The Institutional Review Board / Independent Ethics Committee (IRB/IEC)
According to ICH GCP E6(R2) Section 3, the Institutional Review Board / Independent Ethics Committee (IRB/IEC) is an independent body responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a trial. A key function is to review, approve, and provide continuing review of trial protocols, amendments, and the methods and material to be used in obtaining and documenting informed consent.
SOCRA - Society of Clinical Research Associates ICH Good Clinical Practice Questions and Answers 1
According to ICH GCP E6(R2), which of the following is a primary responsibility of the clinical trial Sponsor?